Limits...
Systematic Review of Randomized Clinical Trials on Safety and Efficacy of Pharmacological and Nonpharmacological Treatments for Retinitis Pigmentosa.

Sacchetti M, Mantelli F, Merlo D, Lambiase A - J Ophthalmol (2015)

Bottom Line: Aims.Although all medical treatments for RP appear safe, evidence emerging from RCTs is limited since they do not present comparable results suitable for quantitative statistical analysis.The limited number of RCTs, the poor clinical results, and the heterogeneity among studies negatively influence the strength of recommendations for the long term management of RP patients.

View Article: PubMed Central - PubMed

Affiliation: Cornea and Ocular Surface Unit, San Raffaele Hospital IRCCS, Via Olgettina, No. 60, 20132 Milan, Italy.

ABSTRACT

Aims. Several treatments have been proposed to slow down progression of Retinitis pigmentosa (RP), a hereditary retinal degenerative condition leading to severe visual impairment. The aim of this study is to systematically review data from randomized clinical trials (RCTs) evaluating safety and efficacy of medical interventions for the treatment of RP. Methods. Randomized clinical trials on medical treatments for syndromic and nonsyndromic RP published up to December 2014 were included in the review. Visual acuity, visual field, electroretinogram, and adverse events were used as outcome measures. Results. The 19 RCTs included in this systematic review included trials on hyperbaric oxygen delivery, topical brimonidine tartrate, vitamins, docosahexaenoic acid, gangliosides, lutein, oral nilvadipine, ciliary neurotrophic factor, and valproic acid. All treatments proved safe but did not show significant benefit on visual function. Long term supplementation with vitamin A showed a significantly slower decline rate in electroretinogram amplitude. Conclusions. Although all medical treatments for RP appear safe, evidence emerging from RCTs is limited since they do not present comparable results suitable for quantitative statistical analysis. The limited number of RCTs, the poor clinical results, and the heterogeneity among studies negatively influence the strength of recommendations for the long term management of RP patients.

No MeSH data available.


Related in: MedlinePlus

Decision tree of randomized clinical trials' selection for inclusion in the systematic review and meta-analysis.
© Copyright Policy - open-access
Related In: Results  -  Collection


getmorefigures.php?uid=PMC4539114&req=5

fig1: Decision tree of randomized clinical trials' selection for inclusion in the systematic review and meta-analysis.

Mentions: The articles' eligibility was initially determined by evaluating the titles, abstracts, and MeSH (medical subject headings). Four observers divided into two groups of two examined all the retrieved 389 abstracts to consider their eligibility. After matching the decisions of the two groups, 360 abstracts were immediately excluded because they were either not randomized, not on medical treatment for RP, or related to different kinds of ocular disease. The remaining 29 complete articles were obtained and printed to identify whether they were suitable for inclusion in the revision and distributed to four researchers randomly divided into two groups of two each. The observers were blinded to the names of the authors and institutions, the name of the journals, the sources of funding, and the sponsors of the studies. The observers of each group were also blinded to the decisions of the other group and trial selection was matched between them. Nine trials were excluded because they did not match one or more inclusion criteria and one was excluded because it was not eligible [16–25]. All the remaining 19 RCTs were included in the systematic review [5, 6, 8–11, 13–15, 17, 26–34] (Figure 1).


Systematic Review of Randomized Clinical Trials on Safety and Efficacy of Pharmacological and Nonpharmacological Treatments for Retinitis Pigmentosa.

Sacchetti M, Mantelli F, Merlo D, Lambiase A - J Ophthalmol (2015)

Decision tree of randomized clinical trials' selection for inclusion in the systematic review and meta-analysis.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4539114&req=5

fig1: Decision tree of randomized clinical trials' selection for inclusion in the systematic review and meta-analysis.
Mentions: The articles' eligibility was initially determined by evaluating the titles, abstracts, and MeSH (medical subject headings). Four observers divided into two groups of two examined all the retrieved 389 abstracts to consider their eligibility. After matching the decisions of the two groups, 360 abstracts were immediately excluded because they were either not randomized, not on medical treatment for RP, or related to different kinds of ocular disease. The remaining 29 complete articles were obtained and printed to identify whether they were suitable for inclusion in the revision and distributed to four researchers randomly divided into two groups of two each. The observers were blinded to the names of the authors and institutions, the name of the journals, the sources of funding, and the sponsors of the studies. The observers of each group were also blinded to the decisions of the other group and trial selection was matched between them. Nine trials were excluded because they did not match one or more inclusion criteria and one was excluded because it was not eligible [16–25]. All the remaining 19 RCTs were included in the systematic review [5, 6, 8–11, 13–15, 17, 26–34] (Figure 1).

Bottom Line: Aims.Although all medical treatments for RP appear safe, evidence emerging from RCTs is limited since they do not present comparable results suitable for quantitative statistical analysis.The limited number of RCTs, the poor clinical results, and the heterogeneity among studies negatively influence the strength of recommendations for the long term management of RP patients.

View Article: PubMed Central - PubMed

Affiliation: Cornea and Ocular Surface Unit, San Raffaele Hospital IRCCS, Via Olgettina, No. 60, 20132 Milan, Italy.

ABSTRACT

Aims. Several treatments have been proposed to slow down progression of Retinitis pigmentosa (RP), a hereditary retinal degenerative condition leading to severe visual impairment. The aim of this study is to systematically review data from randomized clinical trials (RCTs) evaluating safety and efficacy of medical interventions for the treatment of RP. Methods. Randomized clinical trials on medical treatments for syndromic and nonsyndromic RP published up to December 2014 were included in the review. Visual acuity, visual field, electroretinogram, and adverse events were used as outcome measures. Results. The 19 RCTs included in this systematic review included trials on hyperbaric oxygen delivery, topical brimonidine tartrate, vitamins, docosahexaenoic acid, gangliosides, lutein, oral nilvadipine, ciliary neurotrophic factor, and valproic acid. All treatments proved safe but did not show significant benefit on visual function. Long term supplementation with vitamin A showed a significantly slower decline rate in electroretinogram amplitude. Conclusions. Although all medical treatments for RP appear safe, evidence emerging from RCTs is limited since they do not present comparable results suitable for quantitative statistical analysis. The limited number of RCTs, the poor clinical results, and the heterogeneity among studies negatively influence the strength of recommendations for the long term management of RP patients.

No MeSH data available.


Related in: MedlinePlus